Analgesic efficacy of diclofenac and ketoprofen transdermal patches versus ibuprofen oral tablets on pain control after initial arch wire placement in orthodontic patients -a randomized clinical trial study

Analgesic efficacy of diclofenac and ketoprofen transdermal patches versus ibuprofen oral tablets on pain control after initial arch wire placement in orthodontic patients

A randomized, double-blind, parallel group, controlled clinical trial. 48 patients will divided in 3 groups by stratified permuted blocks method.

This study will be done in the orthodontic department of Guilan Dental School. patients will be randomly placed in 3 parallel groups based on preset blocks. first orthodontic appliances will be placed in both jaws. In the ketoprofen and diclofenac group, patients will be asked to apply the patch immediately after placing the archwire, 8 hours later and the next morning. In the ibuprofen group, people will use the pill immediately after placing the archwire, 8, 16 and 24 hours later. The intensity of pain will measure by using the Numeric Rating Scale form. The therapist, researcher and data evaluators are blinded, but the patients are not blinded due to the different nature of the drugs.

Patients who are in the age range of 18 and 30 years old and according to the classification of the American Society of Anesthesiology, are in the ASA I group, will be included. Patients should have 3-6 mm of crowding in both jaws and should not taking any painkillers at the moment. Also, the patient should not report a history of gastrointestinal discomfort or any allergy to aspirin-like drugs such as ibuprofen.

48 patients will divided into 3 groups.16 patients will use 30 mg ketoprofen patch, 16 patients will use 1.3% diclofenac epolamine patch and 16 patients will use 400 mg ibuprofen tablet after initial wire placement.

The pain intensity of the patients immediately after the treatment and 2, 6 hours, while sleeping, 24, 48 hours, 3 and 7 days after the treatment

Method of randomization: block Unit of randomization: stratified Randomization strata: sex, drug How the random sequence was built: permutation Allocation concealment: all the drugs will be packed in same unclear sealed envelops which is not distinguishable for the researcher. This process will be done by a third person that is unaware of the object and protocol of the study. complete explanation of Randomization: Based on Stratified Permuted Blocks, all the patients who agreed to participate in the research will be randomly assigned a drug envelope that contains the studied drugs and their usage method. This operation will be performed by the therapist's assistant. Since 48 patients will enter the randomization process and the variables of gender and type of drug are considered as criteria for classification, the patients will divided into 3 groups of 16 (8 males and 8 females). A, B, C will be labeled on the envelopes. 48 envelopes will divided into two groups, blue and red. If the client is a woman, the red envelope will pickup, and if the client is a man, the blue envelope will be prescribed. The envelopes will be filled with drugs and how to use them according to the order of the following three-number blocks based on the sequence of simple randomization. Blue envelopes: ABC, ACB, BAC, BCA, CBA, CAB, ABC, ACB Red envelopes: CAB, CBA, ABC, ACB, BAC, BCA, ABC, ACB In order to hide the random allocation, the method of Sequentially numbered, sealed opaque envelopes which is abbreviated as SNOSE will be used.

Patients do not become blind due to the prescription of different drugs; But since they do not meet each other, they will not understand the difference of prescription drugs. In this study, the therapist (orthodontist), researcher and statistical analyst will not be aware of randomization and the drugs prescribed for the patients. Only the therapist's assistant (allocating samples to groups) is aware of the prescription drug by coding the drug packages and registering them. Patients will communicate only with the therapist's assistant, they will send him their pain level form after taking the drugs and ask him any questions.

All data in this study can be shared.

The beginning of the access period is after 1403

The data of this study will be available for use by other researchers.

In the case of using the results and methods of this study, the source should be mentioned.

Dr. Yasamin Babaee Hemmati, Guilan dental school

Review and satisfaction of the person responsible for the implementation of this study.